Clovis Oncology to Eliminate 35% of Workforce and Ends All Trials of Lung Cancer Drug Rociletinib

May 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff

BOULDER, Colo. – Following the failure to gain regulatory approval for its experimental drug rociletinib, Clovis Oncology said it was ending all trials of the lung cancer drug and was terminating 35 percent of its workforce to address shifting costs.

Last month after a U.S. Food and Drug Administration (FDA) panel recommended against giving the company’s lung cancer drug, rociletinib, an accelerated approval. More recently, Clovis said it met with the FDA and was told it would receive a Complete Response Letter regarding the drug on or before the June 28 deadline for the regulatory agency to rule on a new drug. A Complete Response Letter is issued by the FDA to notify a company that its new drug is not ready for approval.

In its ruling, the FDA panel said “existing data on rociletinib did not adequately characterize its benefit-risk profile over current treatments,” Reuters reported. Panel members pointed to AstraZeneca ’s similar lung cancer drug, Tagrisso, which was approved in November as an example of a current drug. Also, panel members expressed uncertainty about the proposed dose of rociletinib, Reuters said. This is the second setback for Clovis’ lung cancer drug. In November, the FDA requested additional efficacy data about its lung cancer treatment. These two setbacks for rociletinib give AstraZeneca’s tagrisso additional time to become cemented with physicians as a treatment option.

As a result of the Complete Response Letter, Colorado-based Clovis said it was eliminating enrollment in all ongoing sponsored clinical studies of rociletinib. However, the company did say it would continue to provide drug to patients whose clinicians recommend continuing rociletinib therapy. Based on the Complete Response Letter, Clovis said it was also withdrawing its request for regulatory approval of rociletinib by the European Medicines Agency.

With the termination of rociletinib, the company will reduce its workforce by 35 percent, including full time employees as well as contractors. Clovis said it will also halt any planned hiring activities. The terminations are expected to be complete by the end of the year.

“We are very disappointed in the outcome for rociletinib, as there is a need for additional options for this difficult to treat disease,” Patrick Mahaffy, president and chief executive officer of Clovis said in a statement. “Our focus moving forward is clear: prioritize rucaparib development activity and prepare for its potential U.S. launch, and manage our existing cash into 2018.”

While the company does plan to reduce its workforce, Clovis announced it intends to maintain the U.S. sales force in preparation for the potential U.S. launch of rucaparib, for the monotherapy treatment of patients with advanced ovarian cancer with deleterious BRCA-mutated tumors. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015 and the company has commenced the submission of a rolling New Drug Application for rucaparib. Clovis said it anticipates the completion of its NDA submission by the end of the second quarter of 2016. Clovis said it will also seek approval of rucaparib in Europe later this year.

In its quarterly financial announcement, Clovis said it had $445.5 million in cash, cash equivalents and available-for-sale securities as of the end of March. Clovis reported a net loss for the first quarter of 2016 of $83.4 million, or ($2.17) per share, compared to a net loss of $63.1 million, or ($1.86) per share, for the first quarter of 2015.

Rucaparib may also have a future in other forms of cancer therapy. Clovis recently entered into a clinical trial collaboration with Genentech to evaluate a combination therapy of Genentech’s investigational cancer immunotherapy atezolizumab, an anti-PDL1, and rucaparib for the treatment of gynecological cancers, with a focus on ovarian cancer. The Phase Ib trial is planned to begin enrolling patients during the second half of 2016.

Clovis stock is actually up this morning, trading at $13.26 per share. However, shares overall are down about 40 percent from a March high of $22.51 per share.